Effect of Packaging on Smoking Perceptions and Behavior
CASA
CASA
Sponsor study identifier
NIH
interventional
359
1 country
1
Study Start
February 2016
Actual (reported)Primary Completion
September 2022
Actual (reported)Study Completion
September 2022
Actual (reported)The investigators are addressing two critical areas identified by the FDA: the impact of cigarette packaging and labeling on consumer perceptions and on smoking behavior; and the effectiveness of graphic warning labels on communicating risk of tobacco products. In a randomized controlled trial (RCT), investigators will enroll committed smokers who have no intention of quitting in the next 6-months. The three study arms will be: a) a blank pack with all marketing materials removed (PP); b) The Australian graphic warning images (Australian model-AM); or c) a standard pack with all marketing materials unaltered (ST). The study includes a three month purchasing intervention and continued follow-up through 12 months. Throughout the study interactive text messaging assessments will be used to measure acute and persistent impact of labeling and marketing on perceptions of tobacco products, subjective effects of consumption, awareness of tobacco-related harms, tobacco use behavior, and quitting motivation. At three separate time points, participants will: a) complete a web-based questionnaire b) provide a saliva sample for cotinine analysis. The rigorous design and extensive objective measurements are significant innovations on the currently published research in this field and should lead to significant advances in tobacco regulatory science.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 28, 2016
Actual (reported)February 2016
Actual (reported)February 8, 2016
Actual (reported)September 2022
Actual (reported)September 2022
Actual (reported)Perceptions of Risk From Tobacco Use and Perceptions of Pack Appeal
Changes in perceptions of risk from tobacco use and appeal of tobacco packs
Assessed over 4-months and 12-months
Changes in Awareness and Concern about Health Hazards
Changes in perceptions of harm and potential risks
Assessed over 4-months and 12-months
Changes in routinized behavior and persistence over time.
Decreased willingness to display the pack in public.
Assessed over 4-months and 12-months
Changes in cigarette smoking behaviors.
Changes in the percent smokers, consumption per smoker, and recent quit attempts validated with saliva cotinine.
Assessed over 4-months and 12-months
The intervention to be administered to participants randomized to this group is the purchase of their US brand of cigarettes packaged using standard Australian marketing for three months.
The intervention to be administered to participants randomized to this group is the purchase of their US brand of cigarettes packaged using blank packaging for three months. Blank packaging will indicate participants brand and will not have any brand-related images or labels.
The intervention is the use of the assigned pack design.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of California, San Diego
La Jolla, California, 92093, United States
Pierce JP, Kealey S, Leas EC, Pulvers K, Stone MD, Oratowski J, Brighton E, Villasenor A, Strong DR. Effect of Graphic Warning Labels on Cigarette Pack-Hiding Behavior Among Smokers: The CASA Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2214242. doi: 10.1001/jamanetworkopen.2022.14242.
Strong DR, Pierce JP, Pulvers K, Stone MD, Villasenor A, Pu M, Dimofte CV, Leas EC, Oratowski J, Brighton E, Hurst S, Kealey S, Chen R, Messer K. Effect of Graphic Warning Labels on Cigarette Packs on US Smokers' Cognitions and Smoking Behavior After 3 Months: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2121387. doi: 10.1001/jamanetworkopen.2021.21387.
359 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2016
First Posted
February 8, 2016
Study Start
February 2016
Actual (reported)Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers
Participants assigned the nonintervention group will purchase their US brand of cigarettes in the standard American packaging for three months.
Contact the study team to confirm eligibility.
Primary Completion
September 2022
Actual (reported)Study Completion
September 2022
Actual (reported)Last Updated
January 8, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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